Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course

March 12, 2010 updated by: Danish Cancer Society

Rehabilitation of Cancer Survivors in Denmark: A Randomized Controlled Trial on the Effect of a Multi-focused Psychosocial Rehabilitation Course

This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at a Danish rehabilitation centre for cancer survivors. The investigators hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Worldwide, the number of cancer survivors is increasing. In the Danish population of 5.4 million people, more than 300 000 are cancer survivors. Given the range of physical, psychological and social late effects of cancer and its primary treatment many survivors need tailored rehabilitation interventions. This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at the Dallund Rehabilitation Centre in Denmark. We hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.

Study Type

Interventional

Enrollment (Actual)

513

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Psychosocial Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of breast, colorectal or prostate cancer
  • Completion of primary treatment
  • Ability to participate physically in the activities offered in the intervention

Exclusion Criteria:

  • Acute need for treatment
  • Terminal cancer phase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
Behavioral: Psychosocial rehabilitation course
Groups of 20 cancer survivors participated in a 6-day multi-focused, psychosocial intervention at the Dallund rehabilitation centre. The overall aim was to strengthen each individual's physical, psychological and social functioning. Sharing experiences with other cancer patients and experiencing peer-support was a central issue. The retreat combined lectures, discussions and patient group work on themes such as the treatment of cancer, psychological reactions, spirituality, sexuality and lifestyle. Participants were involved in physical activities, and the daily menu represented a healthy diet. The course was conducted by a multi-disciplinary team. Each participant produced a personal, specific 'action plan', which was intended to serve as a 'booster' after returning to daily life.
NO_INTERVENTION: Control group
Wait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychosocial well-being (as assessed by the EORTC-QLQ C30 Quality of life core questionnaire by the European Organization of Research and Treatment in Cancer (EORTC-QLQ C30) and the Profile of Mood States Short form (POMS-SF)
Time Frame: baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up
self-report questionnaire
baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services
Time Frame: baseline, 1 month, 6 month, 12 month follow-up
self-report questionnaire
baseline, 1 month, 6 month, 12 month follow-up
self-rated health
Time Frame: baseline, 1 month, 6 month, 12 month follow-up
self-report item
baseline, 1 month, 6 month, 12 month follow-up
self-efficacy as measured with the General Self-Efficacy Scale (GSE)
Time Frame: baseline, 1 month, 6 month, 12 month follow-up
self-report questionnaire
baseline, 1 month, 6 month, 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Cancer Society

Collaborators

Randers Regional Hospital
University Hospital Århus, Department of Surgery
University Hospital Århus, Urology Department
Regional Hospital Hørsholm, Department of Breast Surgery

Investigators

  • Principal Investigator: Christoffer Johansen, MD, PhD, Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology and National Centre for Cancer Rehabilitation Research, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (ESTIMATE)

March 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2010

Last Update Submitted That Met QC Criteria

March 12, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225 06 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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